BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFUSOMAT SPACE - US VERSION

    MDR report key: 2243509 · Received August 19, 2011

    Report

    Report Number
    9610825-2011-00104
    Event Type
    Malfunction
    Date Received
    August 19, 2011
    Date of Event
    July 19, 2011
    Report Date
    August 19, 2011
    Manufacturer
    B. BRAUN MELSUNGEN AG
    Product Code
    FPA
    PMA / PMN Number
    K062700
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). B. BRAUN (B)(4). IS SUBMITTING A SINGLE REPORT ON BEHALF OF B. BRAUN (B)(4), AND B. BRAUN (B)(4). THIS REPORT HAS BEEN IDENTIFIED AS B. BRAUN (B)(4). DEVICE EVALUATION RESULTS: THE REPORTED FAILURE WAS NOT REPRODUCED. VOLUMETRIC ACCURACY WAS TESTED THREE TIMES AT A RATE OF 65ML/HR AND 30 MINUTES, CONSISTENT WITH THE PUMP LOG WHEN THE ISSUE WAS IDENTIFIED. IN ALL THREE INSTANCES THE PUMP WAS OPERATING WITHIN SPECIFICATION. VOLUMETRIC ACCURACY WAS ALSO TESTED THREE TIMES AT A RATE OF 130ML/HR AND 30 MINUTES, CONSISTENT WITH THE PUMP LOG WHEN THE ISSUE WAS IDENTIFIED. IN ALL THREE INSTANCES THE PUMP WAS OPERATING WITHIN SPECIFICATION. VOLUMETRIC ACCURACY WAS ALSO TESTED THREE TIMES AT A RATE OF 130ML/HR AND 30 MINUTES, CONSISTENT WITH THE PUMP LOG WHEN THE ISSUE WAS IDENTIFIED. IN ALL THREE INSTANCES THE PUMP WAS OPERATING WITHIN SPECIFICATION. BASED ON THE RESULTS OF THE PUMP INVESTIGATION, NO CONCLUSIONS CAN BE MADE REGARDING THE CAUSE OF THE REPORTED EVENT. ALL AVAILABLE INFORMATION HAS BEEN FORWARDED TO THE ACTUAL MANUFACTURER FOR FURTHER EVALUATION. A FOLLOW UP REPORT WILL BE FILED IF ADDITIONAL PERTINENT INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    AS REPORTED BY THE USER FACILITY: UNDERINFUSING DURING INFUSION OF GENERAL FLUIDS FOR HYDRATION IN OUTPATIENT INFUSION CENTER. INFUSION RATE: CONTINUOUS, BELIEVES THE PUMP WAS INFUSING FOR 1 HOUR BEFORE NOTICING IT WAS UNDERINFUSING - INFUSING AT 65ML/HR - "DID NOT APPEAR TO BE RUNNING AT RIGHT RATE" PUMP LOG SHOWED RATE WAS CHANGED TO 130ML/HR AND THEN CLINICIAN FELT AT THAT TIME THE PUMP WAS UNDERINFUSING. NO PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INFUSOMAT SPACE - US VERSION INFUSION PUMP FPA B. BRAUN MELSUNGEN AG NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other